CHMP recommends approval of Yescarta for diffuse large cell lymphoma and primary mediastinal B-cell lymphoma.- Kite Pharma.

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Yescarta (axicabtagene ciloleucel), from Kite Pharma, intended for the treatment of diffuse large cell lymphoma (DLBCL) and primary mediastinal B-cell lymphoma (PMBCL). As Yescarta is an advanced therapy medicinal product, the CHMP positive opinion is based on an assessment by the Committee for Advanced Therapies. Yescarta, which was designated as an orphan medicinal product on 16 December 2014, was reviewed under EMA�s accelerated assessment programme.

Yescarta will be available as a dispersion for infusion. The active substance of Yescarta is axicabtagene ciloleucel, an autologous, immunocellular cancer therapy which involves reprogramming a patient�s own T cells to identify and eliminate CD19-expressing cells. This is achieved by addition of a transgene encoding a chimeric antigen receptor (CAR).The benefits with Yescarta are its ability to achieve an objective response with a significant duration in patients with DLBCL and patients with PMBCL.

The most common side effects are cytokine release syndrome, infections, pyrexia, diarrhoea, nausea, hypotension and fatigue. The full indication is: "Yescarta is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL), after two or more lines of systemic therapy."